UK-based pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) received approval from China’s National Medical Products Administration (NMPA) for a new indication for its PD-L1 inhibitor Imfinzi (durvalumab). The drug is now approved for use alone in limited stage small cell lung cancer (LS-SCLC) without disease progression after platinum-based radiotherapy and chemotherapy. This makes Imfinzi the first and only immunotherapy approved for this indication in mainland China.
Clinical Trial Results
The NMPA’s decision was based on results from the Phase III ADRIATIC study. In the trial, Imfinzi reduced the risk of patient death by 27% and the risk of disease progression or death by 24% compared to placebo. It also significantly improved progression-free survival (mPFS: 16.6 months vs 9.2 months) and overall survival (expected mOS: 55.9 months vs 33.4 months). Data from the Chinese cohort showed that the survival benefits were consistent with the global population.-Fineline Info & Tech
